The invention relates to a device for securing in-dwelling catheters, sheath introducers, or other temporary or implantable medical devices to patients.
Medical treatments requiring the delivery or drainage of various solutions such as antibiotics, cancer drug therapy, blood draws, abscessed biliary material or urinary tract fluids, rely upon an indwelling catheter or sheath introducer to be inserted into the patient for an extended period of time such as thirty or even sixty or ninety days at a time. A requirement for maintaining the catheter or sheath within a patient for such a period is that the catheter or sheath be secured so as not to move excessively during the treatment.
Typically the physician creates an incision or puncture through the patient""s skin with the goal of reaching an artery, vein or other vessel to allow insertion of a catheter to deliver a therapeutic substance to or aspirate body fluids from a specific anatomical site. Currently catheters and sheaths are secured utilizing a tab or eyelet formed in the luer hub or Y-connector through which a suture is taken through the tab and skin. A standard 2-0 suture is most often used for this purpose, which is tied off thus securing the catheter within the patient""s body. Suturing a catheter to a patient, however, presents several problems: (1) Suturing a catheter to a patient""s body makes it difficult to clean and disinfect the area around the catheter insertion point, resulting in a high rate of infection in the area close to the catheter""s insertion; (2) The catheter is subject to being dislodged from the patient following introduction resulting in migration of the catheter during treatment; and (3) A sutured catheter is subject to a disoriented patient ripping the catheter loose and tearing the suture out. This can result in patient injury and often necessitates costly replacement or additional corrective procedures.
An additional disadvantage of suturing a catheter to a patient is pain and discomfort to the patient during the period of catheterization, as a result of a long-term suture extending through the patient""s skin. Further, different physicians use different suturing and knotting techniques, resulting in a wide variation of pull strengths required to rip out and dislodge the sutured catheter from the patient""s body.
Another securement method utilizes adhesive tape. In this method a layer of tape is placed over a cleaned external site on the patient""s body after catheter or sheath insertion has been accomplished. The catheter or sheath is adhered to the skin by adhesive friction. This method is ineffective at reducing the incidence of infection. Further, it does not prevent the inadvertent and often violent removal of the catheter prior to completion of treatment.
What is therefore needed is a retention device for a catheter, sheath introducer, or other medical devices that allows for simple and effective anchoring to the patient""s body and also reduces the incidence of infection, migration and dislodgment.
In one embodiment, the invention comprises a device for subcutaneously anchoring a catheter within a patient. The device has an anchor sleeve having a chamber defining at least a single port. An anchor mechanism is loaded into the chamber and has a control rod movable within the chamber between a first position and a second position. A tine is fixedly attached to the control rod at a first end, and also has a second free end. The second end of the tine is capable of flexibly and repeatedly moving between a restrained position near the control rod and an unrestrained position away from the control rod. The tine has a trained shape when in the unrestrained position and the length of the tine is such that the tine is restrained within the chamber when the control rod is in the first position. The port is sized and located so the free end of the tine is proximate the port when the tine is in the first position. Moving the control rod from the first position to the second position causes the free second end of the tine to exit the chamber through the port to at least partially assume the trained shape.
In another embodiment, the device is attached to an introducer sheath.
In yet another embodiment, the device is attached to a catheter.